Label: ALLERGY RELIEF- cetirizine hcl 10 mg capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 31, 2018

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  • Active ingredient (in each softgel)

    Cetirizine HCl 10 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • Warnings

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine

    Ask a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • drowsiness may occur
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when drivinga motor vehicle or operating machinery

    Stop use and ask doctor

    if an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breast-feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • Keep Out of Reach of Children

    In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Adults and children 6 years and over: one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms
    • Adults 65 years and over: ask a doctor
    • Children under 6 years of age: ask a doctor
    • Consumers with liver or kidney disease: ask a doctor
  • Other information

    • store between 20°C to 25°C (68°F to 77°F )
    • do not use if imprinted safety seal under cap is broken or missing 
  • Inactive Ingredients

    butylated hydroxytoluene, gelatin, glycerine, polyethylene glycol 400, purified water, sodium hydroxide, sorbitol sorbitan solution, white ink

  • Questions or Comments?

    Call 1-888-952-0050

    Monday through Friday 9AM – 5PM EST

    Manufactured for

    A&Z Pharmaceutical, Inc.
    Hauppauge, NY 11788

  • Package/Label Principal Display Panel

    Cetirizine HCl 10mg Softgels

    Cetirizine HCl 10mg Softgels

  • INGREDIENTS AND APPEARANCE
    ALLERGY RELIEF 
    cetirizine hcl 10 mg capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-392
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-392-251 in 1 CARTON12/16/2014
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07831712/16/2014
    Labeler - Allegiant Health (079501930)
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